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Last Updated: November 22, 2019

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR AZELAIC ACID

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505(b)(2) Clinical Trials for azelaic acid

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT01025635 Safety and Efficacy of Azelaic Acid Foam, 15% in Papulopustular Rosacea Completed Bayer Phase 2 2009-12-01 This study will investigate the safety and efficacy of a new formulation of an existing medication for the treatment of papulopustular rosacea. The study will test the active ingredient plus foam against foam alone.
New Dosage NCT02058628 Comparison of the Efficacy and Safety of Clindamycin + Benzoyl Peroxide Formulation With Azelaic Acid Formulation in the Treatment of Acne Vulgaris Completed GlaxoSmithKline Phase 4 2014-02-01 This is a randomized, comparator-controlled, single-blind, parallel-group study. The current study proposes to compare a fixed-dose combination product containing 3% benzoyl peroxide (BPO) and 1% clindamycin against a cream containing 20% azelaic acid for the treatment of facial acne vulgaris. The results of the study will enable a better assessment of the safety and efficacy of the new dose regime (BPO 3% + clindamycin 1%) in comparison to a well established treatment. Based on the data more evidence based recommendations will be possible to improve the treatment of subjects with acne vulgaris. A total of 220 subjects will be enrolled and will have 5 study visits (Day 1, Weeks 2, 4, 8 and 12). The duration of the study will be over 12 weeks.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for azelaic acid

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00031096 Comparison of Efficacy and Safety of Azelaic Acid 15% Gel With Its Vehicle in Subjects With Mild to Moderate Acne Completed Bayer Phase 3 2002-01-01 Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in male and female patients with mild to moderate acne. Qualified subjects will apply the gel to their face twice a day for a period of 12 weeks. Subjects will be required to return to the doctor's office for up to 5 visits.
NCT00395226 Zinc Sulfate in the Treatment of Rosacea: A Randomized, Controlled Trial Terminated Essentia Health N/A 2006-07-01 Rosacea is a common chronic dermatological condition, characterized by recurrent or persistent redness, permanent dilation of small blood vessel causing small red lesions, and papules/pustules. The signs of rosacea are usually confined to the face, but may appear on the neck, scalp or trunk. Opthalmologic findings are also common. Rosacea is usually described as being most common in fair skinned women over 40. The purpose of the study is to determine whether oral Zinc Sulfate treatment is an effective treatment for facial rosacea.
NCT00403949 A Study of Azelaic Acid (AzA) 15% in Topical Treatment of Mild to Moderate Perioral Dermatitis Completed Bayer Phase 2 2006-11-01 The purpose of this study is to test the efficacy and safety of AzA 15% Gel in the treatment of mild to moderate perioral dermatitis.
NCT00408330 A Study of Azelaic Acid (AzA) 15% Gel in the Treatment of Seborrheic Dermatitis of the Face Completed Bayer Phase 2 2006-12-01 This study is to determine whether a medication on the market for other indications is effective and safe in treating seborrheic dermatitis of the face.
NCT00417937 A Multicenter Trial of a Topical Medication for Papulopustular Rosacea Applied Twice Daily Versus Once Daily Completed Bayer Phase 4 2007-01-01 To assess the efficacy and tolerability of azelaic acid 15% gel applied once daily versus twice daily in the treatment of patients with papulopustular rosacea.
NCT00617903 Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea Completed Bayer Phase 2 2008-01-01 This exploratory study is being performed to determine whether a new form formulation of azelaic acid 15% is effective in the treatment of papulopustular rosecea.
NCT00855595 Efficacy of Topical Azelaic Acid 15% Gel Plus Anti-inflammatory Dose Doxycycline or Metronidazole Gel 1% Plus Anti-inflammatory Dose Doxycycline in Moderate Papulopustular Rosacea Completed Bayer Phase 4 2009-02-01 Subjects with moderate papulopustular rosacea will be treated either with azelaic acid 15% gel topically plus an anti-inflammatory dose of doxycyline (40mg) daily or with metronidazole 1% gel topically once daily plus an anti-inflammatory dose of doxycycline (40mg) over at total of twelve weeks to determine the rapidity of improvement, and the length of time to reach 25%, 50% and 75% clearing compared to baseline.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for azelaic acid

Condition Name

Condition Name for azelaic acid
Intervention Trials
Rosacea 8
Papulopustular Rosacea 7
Acne Vulgaris 3
Skin Manifestations 2
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Condition MeSH

Condition MeSH for azelaic acid
Intervention Trials
Rosacea 17
Acne Vulgaris 3
Melanosis 3
Dermatitis 2
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Clinical Trial Locations for azelaic acid

Trials by Country

Trials by Country for azelaic acid
Location Trials
United States 156
Germany 12
Canada 11
Egypt 1
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Trials by US State

Trials by US State for azelaic acid
Location Trials
Texas 11
North Carolina 9
Florida 7
Virginia 6
Tennessee 6
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Clinical Trial Progress for azelaic acid

Clinical Trial Phase

Clinical Trial Phase for azelaic acid
Clinical Trial Phase Trials
Phase 4 10
Phase 3 8
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for azelaic acid
Clinical Trial Phase Trials
Completed 23
Not yet recruiting 3
Unknown status 1
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Clinical Trial Sponsors for azelaic acid

Sponsor Name

Sponsor Name for azelaic acid
Sponsor Trials
Bayer 14
Galderma Laboratories, L.P. 3
Actavis Inc. 2
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Sponsor Type

Sponsor Type for azelaic acid
Sponsor Trials
Industry 24
Other 9
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